Comprehensive pharmacologic therapy for treatment of obesity

ABSTRACT

The comprehensive pharmacologic therapy for treatment of obesity is a procedure which involves the administration of a desired therapeutic range of Diethylpropion and/or Phentermine in combination with a SSRI medication and nutritional supplementation for brief and long durations which may be 12 months or more. The preferred procedure involves the administration of drugs in combination which are identified as: Citalopram (Celexa) and Phentermine; Citalopram (Celexa) and Diethylpropion; Citalopram (Celexa), Phentermine, and Diethylpropion. In addition nutritional supplementation such as a multivitamin, 5-Hydroxytryptophan, vitamin B6, vitamin C, Tyrosine, Calcium, and Lysine may be used to enhance the performance of the weight loss treatment program.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application from Ser. No. 09/412,701,filed Oct. 5, 1999, now U.S. Pat. No. 6,403,657, the entire contents ofwhich are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

Research has identified that long term use of medications for treatmentof obesity in patients has resulted in many problems. The two mostsignificant problems encountered by patients using medications to assistin weight loss, assuming the absence of irreversible side effects fromthe medications, are that:

The medications stop working during therapy where at least 40% to 50% ofpatients quit losing weight (plateau) on an average of 3.3 months intotherapy; and 5% to 8% of patients who receive drug therapy for weightproblems experience the complication where the medications fail toassist in appetite suppression where the patient therefore does not losesignificant weight.

In the past long term treatment, defined as treatment longer than 3months to many years, with drugs has been a problem due to long termsafety issues including, medication intolerability by the patient,medication side effects and most important ineffectiveness of the drugsor the cessation of benefit of the drugs which in turn causes thepatient to fall out of appetite suppression and terminate weight loss.

A weight loss procedure using SSRI medication is disclosed in U.S. Pat.No. 5,795,895. The potential for patients to obtain goal weight lossunder the process of U.S. Pat. No. 5,795,895 is low, and the failure ofthe drugs to provide a desired level of performance is at the heart ofthe problem.

In the past obesity or weight management procedures, as noted in U.S.Pat. No. 5,795,895, implement a single dosing schedule of SSRImedication for a patient. A single dosing schedule of SSRI medication isnot optimal for a desired level of weight loss performance. Individualsfrequently fail to lose a desired amount of weight when alternativedoses of medication are unavailable.

Second, patients receiving treatment for weight loss through the use ofmedication frequently experience complications such as a cessation ofperformance of the medication due to a “nutritional deficiency”.Frequently it is difficult to predict which patients are likely toexperience unacceptable performance of weight loss medication due to“nutritional deficiencies” associated with calorie deficit's.

It is also problematic to predict the outcome of medication treatmentupon individuals receiving Norepinephrine medications such asPhentermine and/or Diethylpropion. These medications have uniquechemical properties making the outcome of treatment of patientsuncertain. In addition not all medications function to assist in weightloss. In the past SSRI (selective Serotonin Reuptake Inhibitor)medications which have been used in weight loss include FluoxetineHydrochloride (Prozac), Sertraline (Zoloft), Fluvoxamine Maleate(Luvox), and Trazodone Hydrochloride (Desyrel).

The treatment programs for obesity as known also teach away from the useof alternative dosing procedures in the treatment of weight loss.Specifically U.S. Pat. No. 5,795,895 teaches that an SSRI medicationnever needs to be raised to improve the anorexiant effect of weight lossand that the SSRI medication level administered to a patient may beraised to assist in the treatment of coexisting conditions such asdepression.

It is therefore desirable to have a weight loss treatment program for apatient which provides for an effective therapeutic range of availablemedication to enhance desired weight loss. It is also desirable toprovide a weight loss program which minimizes the percent of individualswho do not initially respond to the medication treatment regime or whocease to continue to receive the beneficial effects of the weight lossprogram following the initiation of the medication treatment due tonutritional deficiencies. These and other problems are solved by thedisclosed Comprehensive Pharmacologic Therapy For Treatment Of Obesity.

SUMMARY OF THE INVENTION

The invention embodies the use of Phentermine and/or Diethylpropion withan SSRI medication, Citalopram. The SSRI medication is used in an“effective therapeutic range” to provide optimal results. The treatmentenables individuals to have a much higher expectation of weight loss toachieve a desired weight than the previous known treatments. The methodof weight loss enables individuals to lose weight optimally and safely.With treatment, as individuals lose weight other diseases or illnessescaused by or associated with weight problems get markedly better orresolve completely such as type II diabetes, hypertension,hypercholesterolemia, orthopedic problems, depression, anxiety, panicattacks, migraine headaches, PMS, chronic pain states, fibromyalgia,insomnia, sleep apnea, impulsivity, obsessive compulsive disorder, andmyoclonus. Duration of treatment may be long term, or for life ifneeded, to reduce weight and maintain weight loss as desired by anindividual.

A principal object of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity ofrelatively simple and inexpensive design which fulfills the intendedpurpose of appetite suppression to enable weight loss without fear ofinjury to persons.

Another principal object of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity which iseasy for patients to initiate and continue to effectuate weight loss.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichis effective for all patients attempting to lose weight.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichcontinues to function to enable patient weight loss following theinitiation of therapy by an individual.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichpromotes appetite suppression while simultaneously maintainingnutritional balance for an individual.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichminimizes risk of undesirable side effects for a patient.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichmay be used long term defined as a period of time exceeding threemonths.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichminimizes risk of medication intolerability for a patient.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichminimizes medication side effects and/or complications for a patient.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichassists in empowering a patient to achieve a desired goal weight throughmonitored, healthy, and controlled weight loss.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichis flexible to a patient's needs through the provision of an effectivetherapeutic range of weight loss medication.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichminimizes risk of nutritional deficiency for a patient.

Still another principal object of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichsimultaneously treats other diseases or obesity related illnesses suchas type II diabetes, hypertension, hypercholesterolemia, orthopedicproblems, depression, anxiety, panic attacks, migraine headaches, PMS,chronic pain states, fibromyalgia, insomnia, sleep apnea, impulsivity,obsessive compulsive disorder, and/or myoclonus.

A feature of the present invention is the provision of a comprehensivepharmacologic therapy for treatment of obesity which includes theregulated prescription of an SSRI medication namely, Citalopram in aneffective therapeutic range for a patient to effectuate weight loss.

Another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the regulated prescription of Phentermine in an effectivetherapeutic range for a patient to effectuate weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the regulated prescription of Diethylpropion in an effectivetherapeutic range for a patient to effectuate weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of 5-Hydroxytryptophan by a patient in aneffective therapeutic range to assist in avoiding nutritionaldeficiencies and effectuating weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of weight loss whichincludes the consumption of vitamin B6 by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiency andeffectuating weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of vitamin C by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiency andeffectuating weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of Tyrosine by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiency andeffectuating weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of a multi-vitamin by a patient to assist inavoiding nutritional deficiency and effectuating weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of calcium by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiency andeffectuating weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of Lysine in an effective therapeutic range toassist in avoiding nutritional deficiency and effectuating weight loss.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichinvolves consumption of citalopram by a patient for an initial six (6)day period of time at an initial dosage level where the dosage level maybe subsequently modified after the initial six (6) day period of time tomaximize likelihood of success of weight loss by a patient.

Still another feature of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity whichinvolves the monitoring of a patients weight loss progress throughcalculation of “low weight loss” as defined by a patient weight at aprevious visit added to a patient current weight then divided by two (2)followed by multiplication by 10 and then less the current patientweight, less the patient weight at the previous visit, then multipliedby 3,500 and then divided by the number of days between the previousvisit and the date of the current weight for the provision of a firstsum; calculating a second sum by multiplying a patient goal weight timesten then divided by 0.8928; and comparing the first sum to the secondsum where low weight loss occurs when said first sum is larger than saidsecond sum.

DETAILED DESCRIPTION OF INVENTION

The comprehensive pharmacological therapy for treatment of obesityinvolves the combination of medications within “effective dosing ranges”and “optimal dosing ranges”. The weight loss therapy in general involvesthe use of effective dosing ranges of Citalopram and Phentermine;Citalopram and Diethylpropion; Citalopram, Phentermine, andDiethylpropion to effectuate weight loss in a patient.

The use of Citalopram, Phentermine, and Diethylpropion in effectivedosing ranges as well as optimum dosing ranges in conjunction withproper replacement of vitamins to counter nutritional deficiencysuccessfully resolves two problems unique to weight loss managementprograms which use medications. The use of Citalopram, Phentermine, andDiethylpropion in conjunction with nutritional supplements in effectivedosing ranges generally achieves acceptable weight loss performance forall patients thereby eliminating the failure of the weight loss programto be effective for five percent to eight percent of the patients whohave initiated medication therapy. In addition, the use of Citalopram,Phentermine, and Diethylpropion in conjunction with nutritionalsupplements in effective dosing ranges also continues to function toassist patients to lose weight beyond a three month period of timethereby solving the problem where 40 percent to 50 percent of thepatients undergoing medication therapy encounter a complication wherethe medication therapy stops working at a plateau which occursapproximately three months on average into the medical treatment.

Through the proper use of effective dosing ranges and nutritionalsupplementation, generally all patients successfully lose weight fromthe beginning of therapy and continue to lose weight during medicationtherapy until a desired goal weight is obtained. In addition, thereappears to be no irreversible side effects known during use of themedication combinations of Citalopram, Phentermine and Diethylpropion inconjunction with vitamin supplementation. Proper treatment of weightproblems with the disclosed method is highly effective in resolvingadditional problems caused by or associated with obesity such asdiabetes, hypertension, hypercholesterolemia, orthopedic problems,depression, anxiety, panic attacks, migraine headaches and otherassociated obesity related problems.

The weight loss therapy utilizing medications within an effectivetherapeutic range and/or optimal dosing range provide superior weightloss results in contrast to weight loss treatment programs implementinga single dose SSRI (Selective Serotonin Reuptake Inhibitor) approach. Inthe past, the single dose SSRI medication approach to weight loss ceasedto provide desired performance for a patient resulting in unacceptableweight loss. The failure of the single dose SSRI therapy to adequatelyprovide a desired level of performance frequently results from thepatient having a nutritional deficiency.

The failure of the single dose SSRI therapy to provide for an acceptablelevel of weight loss frequently occurs because Serotonin andNorepinephrine are two neurotransmitters implicated in weight problemsand eating disorders. The chemical pathway for manufacturing Serotoninwithin a body is Tryptophan→Hydroxytryptophan→Serotonin. Vitamin B6 andvitamin C directly and indirectly work as co-factors in this chemicalequation.

The chemical pathway for the manufacture of Norepinephrine within thebody is Tyrosine→Dopamine→Norepinephrine. Patients who are nutritionallydeficient in tryptophan or Tyrosine prior to and/or after initiation ofmedication therapy may develop Serotonin and/or Norepinephrinedeficiencies respectively. Specifically, SSRI medications work withSerotonin and Norepinephrine, such as Phentermine and Diethylpropion,which do not provide adequate performance where a deficiency inSerotonin or Norepinephrine is present. In order to avoid a Serotoninand/or Norepinephrine deficiency a patient under the comprehensivepharmacological therapy for treatment of obesity receives a genericmultiple vitamin, 5-Hydroxytryptophan in a range of 50 mg to 900 mg perday, vitamin B6 in a range of 2 mg to 150 mgs per day, vitamin C in arange of 50 mg to 2000 mg per day, and Tyrosine in a range of 50 mg to4000 mgs per day, as well as calcium in a range of 50 mg to 2000 mgs perday to prevent bone demineralization and Lysine in a range of 50 mg to2000 mgs per day which is used to prevent hair loss and other proteinmetabolism problems while a patient is in a medically induced starvationstate of weight management. In addition, the 5 percent to 8 percent ofthe patients who did not receive any benefit from the initiation ofmedication therapy under the single dose SSRI treatment regimeexperience adequate weight loss under the comprehensive pharmacologictherapy for treatment of obesity when a potential nutritional deficiencywas treated simultaneously to the introduction of the effectivetherapeutic range of SSRI medication, Phentermine or Diethylpropion, inconjunction with the vitamin supplementation. In general, all patientsexperience weight loss under the comprehensive pharmacological therapywhen effective therapeutic ranges of SSRI medication, Phentermine and/orDiethylpropion, and/or vitamin supplementation is used.

Within the comprehensive pharmacologic therapy for treatment of obesitythe use of Phentermine and/or Diethylpropion in generic form, should betaken concurrently with Citalopram (Celexa), to treat exogenous obesity.Medication combinations that may be used are “Phentermine andCitalopram”, “Diethylpropion and Citaliopram”, and Phentermine,Diethylpropion, and Citalopram”. As is known in the art Celexa® isavailable from Forest Laboratories, Inc., of New York, N.Y., and/orForest Pharmaceuticals, Inc., of St. Louis, Mo. Citalopram is a racemicmixture of both the enantiomers S- and R-Citalopram. The S-Citalopramenantiomer is biologically active while the R-enantiomer is inactive. Asis known in the art the S-Citalopram enantiomer is the SSRI chemicalutilized in treating patients. The active S-enantiomer of Citalopram maybe separated from the inactive R-enantiomer Citalopram and individuallyutilized in treating patients for weight loss. The chemical name forCitalopram is Citalopram Hydrobromide;(RS)-1-[3-(dimethylamino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile,hydrobromide, having the chemical formula C₂₀H₂₂BrFN₂₀.

During the first week the patient is instructed to take 15 mg of genericPhentermine by mouth each morning along with 10 mg of Citalopram for thefirst 6 days followed by 20 mg of Citalopram thereafter to decrease thegastrointestinal side effects of the Citalopram. Diethylpropion may beused with or without Phentermine in combination with Citalopram in adaily dosing of 75 mg, short or long acting, if increased appetitesuppression is desired. A few patients experience tolerability issueswith Diethylpropion and a starting dose of 25 mg per day increasedincrementally as tolerated to 75 mg per day may be used. The Phentermineshould be given in the morning to minimize sleep disturbance,experienced on start-up. The SSRI medications may be given any timeduring the day with preferential time being at noon. In addition toCitalopram other SSRI medications may include Fluoxetine Hydrochloride(Prosac), Sertralin (Coloft), Fluvoxamine Maleate (Luvox), and TrazodoneHydrochloride (Desyrel).

On start-up, to minimize the possibility of medication ineffectivenessthe patient should consume 50 to 200 mg of 5-Hydroxytryptophan a day,Vitamin B6 in the dosing range of 2 to 150 mg per day, Vitamin C in thedosing range of 50 to 2000 mg per day and optionally Tyrosine in thedosing range of 50 to 4000 mg per day as well as Calcium in the dosingrange of 50-2000 mg per day and Lysine in the dosing range of 50 to 2000mg per day.

After the first week of treatment the patients should be evaluated forcontinued appetite suppression. Appetite suppression may be identifiedthrough patient questioning to ascertain “significant hunger”, snacking,nibbling, failure to adhere to diet, or using willpower which inducesstress to follow the diet. If appetite suppression does not appear tohave been obtained, then the medications and/or nutritional supplementsmay be further adjusted as needed.

At a second visit at the end of the first week of treatment, the patientshould have the Phentermine increased from 15 mg taken in the morning to15 mg taken in the morning and 15 mg taken at noon unless tolerabilityissues exist, and the Citalopram dosage should now be at a 20 mg dailytaken at noon or 10 mg taken at noon and 10 mg taken in the lateafternoon (approximately one hour before the last meal of the day).

Citalopram may be increased in 20 mg increments in the “effectivetherapeutic range” of 20 mg to 80 mg per day. Phentermine is started at15 mg per day the first week followed by a total daily dosing of 30 mgper day recommended as divided into doses of 15 mg in the morning and 15mg at noon if no problems with tolerance are noted for the patient. Onsubsequent visits, Phentermine may be increased to a total daily dosingof 60 mg per day preferably as divided into doses of 30 mg in themorning and 30 mg at noon. The Phentermine has an “effective therapeuticrange” of 15 mg to 60 mg per day. The daily “optimal dosing range” formost patients consuming Citalopram is 20 mg to 40 mg per day. The daily“optimal dosage range” for most patients with Phentermine is 30 mg to 60mg per day.

Citalopram may be provided in a dosing range of 10 mg per day for thefirst six days of therapy, to minimize start-up side effects, followedby 20 mg per day thereafter. At subsequent visits, if a patient isexperiencing low weight loss or significant hunger, Citalopram may beincreased in 20 mg increments in the “effective therapeutic range” of 20mg to 80 mg per day. The Phentermine may have an “effective therapeuticrange” of 15 mg to 60 mg per day. Diethylpropion dosage in the amount of75 mg per day is given. The problems with tolerance developDiethylpropion dosage may be started at 25 mg per day and increased in25 mg per week increments to a total daily dosing of 75 mg if “lowweight loss” or “significant hunger” is present. The “effectivetherapeutic range” of Diethylpropion is 25 mg to 75 mg per day. Thedaily “optimal dosing range” for most patients with Citalopram is 20 mgto 40 mg per day. The “optimal therapeutic range” for most patients forPhentermine is 30 mg to 60 mg per day. The “optimal therapeutic range”for most patients with Diethylpropion is 75 mg per day.

At initiation of therapy the nutritional supplement dosing schedule maybe to provide 50 mg to 200 mg of 5-Hydroxytryptophan, 50 mg to 100 mg ofvitamin B6, 50 mg to 1000 mg of vitamin C, 500 mg to 1000 mg ofTyrosine, 500 mg to 1000 mg of Lysine, and 500 mg to 1000 mg of calcium.If after the first two visits the patient is experiencing “low weightloss” or “significant hunger” the 5-Hydroxytryptophan may be increasedin 100 mg to 300 mg per week increments to a maximum dose of 900 mg perday. If the patient is still refractory to treatment at that point, theTyrosine may be increased in 500 mg to 1000 mg increments to a maximumdose of 4000 mg per day. Once a patient no longer has “significanthunger” or “low weight loss” the 5-Hydroxytryptophan and Tyrosine may beincrementally decreased back to starting doses or to the lowest doseneeded to insure that the patient does not again resume “significanthunger” or “low weight loss”.

Patients should further schedule follow up appointments no more thanevery 2 weeks. At any patient visit should the patient be experiencing“low weight loss” or “significant hunger”, the patient should schedule afollow up visit in 1 week.

“Low weight loss” is defined as:

1. Formula 1=[(((weight at previous visit+currentweight)/2)×10)−((weight loss since last visit×3,500)/number of dayssince last visit)]

2. Formula 2=[((goal weight*10)×0.8929)]

3. When the answer to Formula 1 is greater than the answer to Formula 2the patient has “low weight loss”.

After the second visit if the patient still is experiencing “significanthunger”, then the Citalopram should be increased to 40 mg. At subsequentvisits if “significant hunger” is still present Citalopram may beincreased incrementally to 80 mg per day total dosing. The Phenterminemay also be increased incrementally to 60 mg per day total dosing(generally given as 30 mg in the morning and 30 mg at noon). TheDiethylpropion may be increased incrementally to 75 mg per day totaldosing if regular release is utilized.

During subsequent visits while the medications are being increased, thenutritional supplements should also be adjusted. The patient should beconsuming the basic doses of Vitamin B6, Vitamin C, as well as Tyrosine,Calcium, a multi-vitamin and Lysine. The 5-Hydroxytryptophan should beincreased incrementally in 50 to 300 mg doses from 50, 100, 200, or 300mg starting doses in 100 mg to 300 mg increments to a maximum dosing of900 mg per day following each visit as the patient continues to expresshunger. Once the patients are in adequate appetite suppression for 7-10days, the 5-Hydroxytryptophan may be decreased to the first initial dosebelow which the patient experienced appetite suppression that being 300or 100 mg per day. The 300 mg dose should be maintained at that levelfor 2-3 weeks prior to trying to decrease the dosage further to 100 mgper day of 5-Hydroxytryptophan. If at any time the patient does begin toexperience hunger after lowering 5-Hydroxytryptophan doses, then thedaily dose should be increased back to the dosage that induced fullappetite suppression. It should be noted that for patients who havepreviously consumed 5-Hydroxytryptophan for appetite suppressionsuccessfully, and who have terminated the consumption of5-Hydroxytryptophan and experienced hunger, then the patient will likelybe required to restart the consumption of 5-Hydroxytryptophan from theinitial dose and duplicate the amount of time necessary to return tofull appetite suppression. For example, a patient who initially received20 days of additional 5-Hydroxytryptophan to obtain appetite suppressionand where the patient was no longer taking the additional5-Hydroxytryptophan following a loss of appetite suppression whichresulted in the return of hunger then, the patient will likely berequired to receive 20 additional days of 5-Hydroxytryptophan to onceagain return to full appetite suppression. All patients consuming5-Hydroxytryptophan should be encouraged to increase the dosage of5-Hydroxytryptophan if hunger is experienced upon the lowering of thedosage.

Once a patient has obtained adequate appetite suppression throughincreased dosage of Citalopram within the “effective therapeutic range”of 10 mg to 80 mg per day, and with regulation of nutritionalsupplements, an attempt should be made within 1 to 3 months afterappetite suppression is induced to lower the patient's Norepinephrineand SSRI medication dosage. Many patients at the point in time are ableto be maintained on lower dosages of SSRI medication through nutritionalsupplementation which enhance the underlying Serotonin andNorepinephrine levels.

As the patients are treated with weight management, calorieprescriptions may be needed to ensure that the patient is fullycognizant of their food intake while in appetite suppression. Calorieprescriptions are not only important from the aspect that the patientswill lose optimal weight by eating at their calorie prescription, but itis also important to make sure the patients are consuming enough foodand not entering into a starvation state with subsequent ketosis whichis cardiotoxic. A calorie prescription developed may be:

1. CALRX=((goal weight (which in most cases we use the high end weighton the Metropolitan Tables)×10)−500).

Patients should use ketostix at least once daily to ensure that they arenot going into a true starvation state and experiencing ketosis.Exposure to a deep state of ketosis for a long period of time may befatal from cardiac dysrhythmia.

An initial medical work-up for patients may include a thyroid panel.Approximately 12.5% of patients having obesity problems also have neverbeen properly diagnosed for a hypothyroid abnormality. It may also bebeneficial to perform a chem-screen panel to ensure that electrolytebalance and organ function is intact prior to inducing patients into amedical starvation state of weight loss. A cell blood count, a urineanalysis, as well as an EKG may also assist to insure that there are nounderlying heart problems which may be exacerbated by very low caloriediet.

With regards to exercise, patients are instructed that, “exercise is notto lose weight, it is to tone the body”. Patients are already losingoptimal weight through the calorie prescription. If patients desire toreceive a high intensity work-out the patients will be required to eatmore food to ensure that they do not go into ketosis from lowering theireffective caloric intake by burning extra calories.

With regards to treatment of type II Diabetes, most diabetics mayterminate insulin consumption safely with initiation of therapy.Patients should be switched over to maximum dose double oralhypoglycemic therapy and evaluate their blood sugars four times a day.Further the patients may be placed on a sliding scale with regularinsulin where the patient may respond to each individual blood sugarreading with appropriate levels of Regular insulin should their bloodsugars be elevated. Most type II diabetics will need no further shots ofinsulin after initiation of therapy. There is a need for moderately goodcontrol of Diabetes prior to initiation of therapy. As type II diabeticscontinue to lose weight most reach a point where all diabetesmedications may be withdrawn. Patients with blood sugars that arerelatively high should have them brought under control prior toinitiation of therapy.

If weight loss is low during therapy and the patient claims that theyare in good appetite suppression and not experiencing “significanthunger”, the patient's calorie counting should be vigorously evaluatedand proper teaching undertaken with the patient as well asconsiderations made for increasing the patients medication and/ornutritional supplement dosing as previously discussed.

After a patient reaches goal weight or ideal body weight, the patientneeds to be individually assessed for long term maintenance to preventweight regain. If the patient has a history of having medically dietedin the past and gaining significant weight back, these patients maysimply be maintained on lower doses of medications. If the patient doesnot have a history of medically dieting in the past, then themedications may be removed for four to eight weeks in order to evaluatethe continuing need for medications to maintain weight loss. Themedications for patients placed directly on maintenance and continued onmedications, should be reduced progressively back at 2 week incrementsto the lowest possible level to maintain weight. While on maintenance apatient should continue on nutritional supplementation as describedpreviously. Any of the previously discussed combinations of medicationsare acceptable in maintenance as long as the patient tolerates thecombination and is effective maintaining weight loss.

As far as standards for implementing care in patients the “Body MassIndex” (BMI) is used. The BMI is defined as the body weight in kilogramsdivided by the square of the height in meters. If the patients have BMIof 30 or above they are a candidate for weight therapy and if the BMI is25 or above with significant co-morbidity such as Diabetes,Hypertension, Hypercholesterolemia, they patient can be treated at a BMIof 25 or greater.

There are numerous medical counter indications to weight therapyincluding severe tremor, uncompensated for Schizophrenia, Activetachycardia, Severe narrowing of Glaucoma, Symptomatic gall stones,obstructive enlarged prostate, history of allergy intolerance toPhentermine or SSRI medication, or Diethylpropion, Diabetes out ofcontrol, severe hypertension, angina pectoris, recurrent myocardialinfarction, congestive heart failure, epilepsy, hyperthyroidism. Inaddition patients taking the medications Beta blockers, Theophylline,Ritalin, oral Beta-agonist should not take weight loss medications inaddition to these other medications. Caffeine in the diet should also bereduced.

The adjustment of SSRI medications within a dosing range is much moreeffective than utilization of a single dose of medicine to treat allpatients. By increasing medications in the dosing range and usingnutritional supplements an effective appetite suppression may be inducedwith all patients, including patients who are new to therapy and thosepatients who have prior experience with the medications.

The above Examples and disclosure are intended to be illustrative andnot exhaustive. These examples and description will suggest manyvariations and alternatives to one of ordinary skill in this art. Allthese alternatives and variations are intended to be included within thescope of the attached claims. Those familiar with the art may recognizeother equivalents to the specific embodiments described herein whichequivalents are also intended to be encompassed by the claims attachedhereto.

REFERENCES

Safer than Phen-Fen (copyright 1997), Written by Michael Anchors, MDPh.D. Pulmonary Vascular Disease, Medical Clinics of North America Nov.6, 1997, Written by Donald Heath, MD Ph.D.

The “Phen-pro” Diet Drug Combination Is Not Associated with ValvularHeart Disease. Jan. 12, 1998 Archives of Internal Medicine. Written by:Len Griffen, MD and Michael Anchors, MD Ph.D.

Fluoxetine (Prozac) and Other Drugs for Treatment of Obesity, Nov. 25,1994 The Medical Letter.

The Treatment of Obesity with Drugs. January 1998. The American Journalof Clinical Nutrition. Written by Jules Hirsch Rockefeller University.

Asymptomatic Mitral and Aortic Valve Disease Is Seen in Half of thePatients Taking “Phen-fen”. Jan. 12, 1998. Archives of InternalMedicine. Written by: Len Griffen, MD and Michael Anchors, MD Ph.D.

What is claimed is:
 1. A method to facilitate weight loss for a patient not suffering from depression, said method comprising: A. administration of a selective Serotonin reuptake inhibitor (SSRI); B. administration of Phentermine; and C. administration of 5-Hydroxytryptophan, Vitamin B6, and Vitamin C, wherein said SSRI, said Phentermine, said 5-Hydroxytryptophan, said Vitamin B6, and said Vitamin C are administered in an effective therapeutic range to effectuate weight loss.
 2. The method according to claim 1, said effective therapeutic range comprising: A. the administration of 10 mg of said SSRI each day for a period of six days followed by the administration of a daily dosage of between 10 mg and 80 mg of said SSRI; B. the administration of 15 mg of said Phentermine each day for said period of six days followed by the administration of a daily dosage of between 15 mg and 60 mg of said Phentermine; and C. the administration of 50 mg to 900 mg of said 5-Hydroxytryptophan each day, 2 mg to 150 mg of Vitamin B6 each day, and 50 mg to 2000 mg of Vitamin C each day until a target weight for said patient is obtained.
 3. The method of claim 2 further comprising the administration of Tyrosine, a multivitamin, calcium, and Lysine.
 4. The method according to claim 3, further comprising the administration of: A. 50 mg to 4000 mg of Tyrosine each day; B. 50 mg to 2000 mg of Calcium each day; and C. 50 mg to 2000 mg of Lysine each day.
 5. The method according to claim 4, wherein said administration of said SSRI and the administration of said Phentermine is increased when said patient experiences low weight loss, said low weight loss comprising: A. said patient weight at a previous visit plus said patient current weight first divided by 2 and then multiplied by 10, less said current patient weight, less said patient weight at said previous visit, multiplied by 3500, divided by the number of days between said previous visit and said current weight for the provision of a first sum; B. calculating a second sum by multiplying a patient goal weight by 10 and then divided 0.8929; and C. comparing said first sum to said second sum where low weight loss occurs when said first sum is larger than said second sum. 